The article MindMed Faces Tough IP Questions (and Publishes Positive Trial Results) was originally published on Microdose.

MindMed’s been in the news as of late. Two weeks ago Mindmed stock shot up over 60%, apparently due to meme-stock star Jake Freeman amassing “an activist stake” in the company.

The Freeman family is now causing another buzz, this time negative. Jake Freeman’s father, Dr. Scott Freeman is a MindMed co-founder and former CMO, and he’s suing fellow MindMed co-founder and former co-CEO Stephen Hurst. The complaint alleges that Hurst was a very bad boy, carrying out schemes to exercise control over the company and put MindMed in a bad position over its IP protection of LSD and BOL-148. The lawsuit says Hurst took part in fraud, extortion, and embezzlement that hurt MindMed executives and shareholders. There’s also allegations that MindMed’s IP protection was directed to Ceruvia Lifesciences, putting MindMed in a potentially unfavorable future IP position.

It’s complicated, and the allegations are complex, involving patent protection and several players and companies. The dust needs to settle to get some clarity, but that hasn’t stopped the mild panic from starting.

Reddit boards are afire with doomsday predictions (many of these retail investors seem born of the GameStop meme-stock breed and tend towards overreaction and Wall Street conspiracies, sorry guys). But the fact remains that MindMed stock is down over 25% this week, likely due to questions over the company’s IP.

Lawsuits don’t necessarily mean something is wrong, and Freeman has publicly stated this complaint is not against MindMed, but against a former executive (Hurst). Still, MindMed needs to address investor’s IP concerns asap to keep confidence in the company’s prospects. For now, here’s their only public statement.

Will this be a big problem for MindMed’s future commercial potential? Time will tell. But at minimum it shines a light on MindMed’s potential IP blindspots and could be a blessing, forcing them to step up their IP game.

In the meantime, the company continues pushing its main program forward, with positive results from its Phase II study published in the peer-reviewed scientific journal Biological Psychiatry.

Take note of CEO Rob Barrow throwing in a mention of their IP protection:

“Patient dosing in our Phase 2b trial for MM-120 is ongoing and we are continuing to leverage this momentum in our mission to bring our novel therapeutic option to market. We believe MM-120 has a highly attractive commercial opportunity given its potential benefits for GAD patients. We also continue to advance our efforts to further strengthen the protection of our intellectual property and proprietary technology that is important to our business…”

See the full press release below.

MindMed Announces Positive Results from Collaborators’ Placebo-Controlled Investigator-Initiated Trial Published in Peer-Reviewed Journal

– Data from University Hospital Basel (UHB) study supports the clinical development of MindMed’s proprietary MM-120 product candidate for Generalized Anxiety Disorder (“GAD”) –

– Patient dosing in Phase 2b trial ongoing for MM-120 in GAD–

– MindMed currently owns and retains all clinical data and manufacturing rights for MM-120 and intends to continue broadening its intellectual property portfolio –

NEW YORK, Sept. 8, 2022 /CNW/ — Mind Medicine (MindMed) Inc. (NASDAQ: MNMD), (NEO: MMED), (the “Company” or “MindMed”), a clinical stage biopharmaceutical company developing novel products to treat brain health disorders, today announced that the manuscript “Lysergic Acid Diethylamide-Assisted Therapy In Patients With Anxiety With And Without A Life-Threatening Illness A Randomized, Double-Blind, Placebo-Controlled Phase II Study,” has been published in the peer-reviewed scientific journal Biological Psychiatry. The paper expands on previously reported positive data that was featured in an oral presentation at the PSYCH Symposium in London on May 11, 2022.

Rob Barrow, CEO and Director of MindMed, stated: “This paper further reinforces the positive preliminary evidence for LSD in patients who suffer from anxiety disorders. Acute administration of LSD produced long-lasting and notable reductions of anxiety and comorbid depression symptoms for up to 16 weeks. These results are encouraging and supportive of our proprietary MM-120 product candidate in its potential to one day offer a therapeutic benefit for patients suffering from GAD after just a single-dose administration.”

“Patient dosing in our Phase 2b trial for MM-120 is ongoing and we are continuing to leverage this momentum in our mission to bring our novel therapeutic option to market. We believe MM-120 has a highly attractive commercial opportunity given its potential benefits for GAD patients. We also continue to advance our efforts to further strengthen the protection of our intellectual property and proprietary technology that is important to our business. Our exclusive rights to the data from this study through our strong and productive collaboration with the Liechti Lab at UHB only enhance our leading position in the development of MM-120. We continue to protect and build on this position by filing multiple layers of intellectual property applications and continue to retain clinical data, manufacturing rights to and know-how for our proprietary MM-120 product, which we believe offers significant advantages as a pharmaceutical product over the free-base form of LSD.”

Daniel R. Karlin, MD, MA, Chief Medical Officer of MindMed, added, “GAD is a debilitating mental health disorder that is often insufficiently managed with available medications and can significantly impair one’s ability to function. We are encouraged by the lasting effects observed in this robust clinical study, which further highlights the therapeutic potential of MM-120 to address the unmet need for novel treatment options.”

About MM-120 (LSD D-Tartrate) and Phase 2b Trial in GAD

• MindMed’s lead drug candidate, MM-120, is a proprietary, pharmaceutically optimized form of LSD D-Tartrate that is separate from the free-base form of LSD (CAS-50-37-3).
• The Company also has a broad, multi-year exclusive research partnership with UHB in addition to exclusive worldwide rights to data, compounds and patent rights associated with UHB’s research on LSD and other compounds, including data from preclinical studies and ongoing LSD trials.
• The Phase 2b trial in patients diagnosed with GAD is a multi-center, parallel, randomized, double-blind, placebo-controlled, dose-optimization study. The trial is expected to enroll 200 participants who will receive a single administration of up to 200 µg of MM-120 or placebo.
• The primary objective is to determine the reduction in anxiety symptoms four weeks after a single administration of MM-120, compared across the five treatment arms. Key secondary objectives, measured up to 12 weeks after the single administration, include assessments of safety and tolerability as well as quality of life. More information about the trial is available on MindMed’s website (mindmed.co) or on clinicaltrials.gov (NCT05407064).

About MindMed’s Intellectual Property Strategy

• As detailed in the Company’s 2022 annual report on Form 10-K, MindMed’s patent strategy includes pursuing protection for compositions of matter, methods of treatment, and diagnostic devices and analytics related to psychedelics. MindMed’s patent portfolio includes 26 pending U.S. applications, and 12 pending Patent Cooperation Treaty (PCT) applications. If granted, patents based on these applications have a projected expiry date beginning in 2040.
• The Company intends to continue its multifaceted strategy of seeking and maintaining patents intended to cover its product candidates and compositions, their methods of use and processes for their manufacture, and any other aspects of inventions or applications such as digital medicine approaches that are commercially important to the development of our business. We retain all rights to the intellectual property we have acquired and developed internally and remain highly confident in our intellectual property strategy.

About MindMed

MindMed is a clinical stage biopharmaceutical company developing novel products to treat brain health disorders. Our mission is to be the global leader in the development and delivery of treatments that unlock new opportunities to improve patient outcomes. We are developing a pipeline of innovative drug candidates, with and without acute perceptual effects, targeting the serotonin, dopamine, and acetylcholine systems.

MindMed trades on NASDAQ under the symbol MNMD and on the Canadian NEO Exchange under the symbol MMED.

Read More